Investigator-initiated clinical trials: a community perspective
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Presentation by Miranda Cumpston, ACTA, to the 'Unlocking value from publicly funded Clinical Research Data' workshop, cohosted by ARDC and CSIRO at ANU on 6 March 2019.
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Investigator-initiated clinical trials: a community perspective
- 1. Miranda Cumpston Senior Program Manager Unlocking the value from publicly funded Clinical Research Data Canberra, 6 March 2019 ACTA gratefully acknowledges operational funding from the Australian Government’s Medical Research Future Fund Investigator-initiated clinical trials: a community perspective
- 2. National peak body supporting and representing investigator-initiated clinical trials sector, including • Clinical Trial Networks (CTNs) • Clinical trial Coordinating Centres (CCs) • Registries That’s more than 10,000 clinician-researchers Who is ACTA’s community?
- 3. ⟩ Profiling Networks ⟩ 10 years ⟩ > 1,000 studies ⟩ > 1 million participants ⟩ > $1 billion research funding ⟩ Substantive proportion of NHMRC budget for clinical trials CTNs in Australia
- 4. What do our trials look like? • Investigator-initiated • Focused on questions in current practice • Clinicians, not all with academic roles • Increasingly multi-site or multinational • Outcome data • Collected for the trial OR routine data collection • Novel designs • Adaptive and platform trials • Funding • For trials: grants, occasional industry collaboration • For networks: varies, but often limited
- 5. How do trialists feel about ‘unlocking’ trials I want my trial to impact health (but I have questions about process) I want to access linked data from other datasets I’m already working on re-use projects! I’m not sure about this…
- 6. AHMAC: 3 functions of the healthcare system Health care ResearchEducation ACTA: It follows that healthcare improvement is a primary purpose of research data collected within the healthcare system
- 7. It’s already happening • Networks already respond to requests to manually share data • ICMJE requires data sharing statement • NHMRC “strongly encourages researchers to take reasonable steps to share research data and associated metadata” • Trials conducted in Australia are also subject to international funding and laws • Data from Australian trial participants already being shared
- 8. What process issues should be addressed? • Privacy/data protection • Participant consent • New trials, trials already commenced • Opt-in, opt-out, waived • Opportunities for future research • IP and acknowledgement for subsequent research outputs • Competition with better resourced groups • Commercial groups with conflict of interest • Funding/resources for data preparation and sharing • Cleaning, derived variables, variable names, data dictionary, etc. • Technical knowledge/capacity to implement • Standards, platforms, integration/APIs with existing applications
- 9. None of these issues is insurmountable …some have been solved already • Shared decisions about acceptable practice around ethics and data protection • Standards for minimum datasets, meta-data, ontologies, endpoints, etc. • Technical solutions to FAIR principles • Resource solutions: who, when, how • Implementation: so sharing and re-use will both happen
- 10. Thank you
Notes de l'éditeur
- … everybody with a stake in evidence-based healthcare Commonwealth and state governments, policy makers and regulators Healthcare professionals and institutions Universities and medical research institutes Research funders Patient and consumer groups Industry and health insurers
- Funding for trials: grants limited in what they cover, struggle to cover site costs (e.g. pharmacy, sample transport, staff time), much lower than pharma trials. Funding for networks : Cancer Australia funds around 16 cancer-related networks, the others patched together funding in various ways, e..g CRE, College support, other sources. Not all can afford e.g. full time EO, which limits what the network can do. POINT: not to complain about funding but to indicate that there’s not a lot of fat to support additional work that isn’t explicitly funded.
- Many trialists also working on various re-use projects – some are working with linked data from other sources, some working on evidence synthesis and guideline development, some may already be sharing open access data. We want to be able to access existing data held by administrative and clinical entities, registries etc. Hospital-based electronic medical records are coming and being able to think about ways in which these can be accessed for registries and clinical trials is a vital issue. For those who are resistant, the world has moved and a data sharing policy is an ICMJE requirement for all clinical trials that commence recruitment now.
- Note: Confirmed with Chris Brook that the 3 components are an AHMAC definition, not a personal statement of his. The explanatory extension that this means healthcare improvement is a primary goal of research, he says, is not attributable to AHMAC or to Chris.
- None of these problems is insurmountable, and many have been solved for existing platforms MRCT standard consent clause Vivli technical solutions